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Re: learningcurve2020 post# 684114

Tuesday, 04/09/2024 9:58:33 AM

Tuesday, April 09, 2024 9:58:33 AM

Post# of 687940

Anticipated Benefits of the Flaskworks System

The Company believes that implementing the Flaskworks system will deliver multiple benefits:

Manufacturing using the “closed” Flaskworks system can be done in lower grade clean rooms (grade C labs) that are substantially less expensive to build out and to operate than the higher grade clean rooms (grade B labs) required for the existing “open” process. As the Company has previously reported, it has purposefully built out its Sawston facility in stages, both to manage capital expenditure and in anticipation of being able to transition away from the more expensive labs as manufacturing technology advanced.

Manufacturing using the “closed” Flaskworks system will also enable products for multiple patients (potentially up to a dozen or so) to be produced in a single (larger) manufacturing lab at the same time. Under the present “open” process (as with most cell therapy production processes to date), only 1 patient’s product can be made at a time in each manufacturing lab, and the lab must go through special cleaning in between each product.

With the Flaskworks machine performing the manufacturing process steps, the manufacturing personnel will only need to operate and oversee the machine and transfer culture vessels onto and off of the machine for these manufacturing steps rather than performing the steps by hand. This will be crucial for scale up to producing DCVax-L for very large numbers of patients, because the personnel can be drawn from a much wider pool and not just the very limited number of technicians able to perform the process steps by hand in an essentially artisan process. — NWBIO

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